Phase 4
N=35
UNderstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study
Unconsciousness · Consciousness
Bottom Line
View on ClinicalTrials.gov: NCT03284307 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Occipital Delta Power Spectral Density by Conscious State and Study Group. — 2.37; 1.62; 2.05; 2.1 log10(μV^2) — p=0.012
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexmedetomidine (Drug); Ketamine (Drug); Propofol (Drug); Midazolam (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occipital Delta Power Spectral Density by Conscious State and Study Group. |
2.37; 1.62; 2.05; 2.1; 2.57; 1.7 | 0.012 sig |
| SECONDARY Number of Instances of Disconnected Conscious Experience (Dreaming) vs Connected Conscious Experience (Awareness of External World). |
70; 180; 56; 226; 30; 22 | — |
| SECONDARY Effect of Study Drug on Ability to Correctly Identify Shapes/Images |
8.83; 9.29; 9.45; 7.85; 8.2; 6.94 | 0.134 |
| SECONDARY Effect of Study Drug on Ability to Correctly Identify Images |
0.916; 0.899; 0.91; 0.793; 0.763; 0.734 | <0.001 sig |
| SECONDARY Effect of Study Drug on Ability to Form Implicit Memory |
8; 8.17; 9 | 0.5 |
Summary
This study will be a single-site, controlled, unblinded study at the University of Wisconsin to examine changes in the electroencephalogram during anesthesia and waking.
Eligibility Criteria
Inclusion Criteria
- Age 18-40
- In good health, determined by the PI on the basis of medical history and a standard assessment for anesthesia to be documented as part of the study record
- Right handed, to standardize for asymmetry in brain functions
Exclusion Criteria
- Adults 40 years old
- Pregnancy confirmed on pregnancy test on day of sedation
- Contraindication to anesthesia or allergy to study drug
- Difficult anesthesia: American Society of Anesthesiologists Physical Status greater than 1, per the discretion of the PI. Examples of ASA status include, but are not limited to:
- Any systemic disease present, such as diabetes, cardiac, pulmonary, or other acute or chronic disorder, or history of smoking
- Narrow angle glaucoma
- Abnormal airway examination
- Any abnormality on medical history and physical examination
- Snoring or sleep disorders including apnea
- Antecedent pulmonary aspiration risk (e.g., history GI reflux, heartburn, hiatal hernia)
- Adverse reaction or allergy with anesthesia or other sedatives
- Chronic medication use
- History of difficult anesthesia, laryngoscopy or intubation
- Family history of difficulty with anesthesia or sedation
- History of vertigo, nausea or vomiting after anesthesia
- BMI > 35
- Contraindication to HD-EEG, TMS or MRI for relative parts of the procedures. MRI exclusion criteria: presence of metallic or electronic implants; history of claustrophobia. TMS exclusion criteria: Presence or history of medical conditions that could increase the chance of seizures (e.g. - stroke, aneurysm, brain surgery, structural brain lesion) cranial metal implants; structural brain lesion; devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator); history of head trauma with loss of consciousness for greater than 5 minutes; family history of seizures; history of antecedent mood disorder.
- Exclusion from Dexmedetomidine:
o Resting heart Rate<60 bpm
- Exclusion from Propofol:
o Reported egg allergy
- Exclusion from Ketamine:
- History of post-operative nausea and vomiting
- History of motion sickness
Additional exclusion criteria on the day of sedation:
- Anything to eat or drink for the preceding 8 hours
- Any use of over-the-counter or recreational drugs (including alcohol or tobacco) within the preceding 24 hours
- Any use of sedative or sleep agents within the preceding 24 hours
- Recent change in health, including cough, cold, or fever
- Exposure to anesthesia or sedation in the last 6 days
Data sourced from ClinicalTrials.gov (NCT03284307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.